Search / Trial NCT00002180

A Study of PMPA in HIV-Infected Patients

Launched by GILEAD SCIENCES · Aug 30, 2001

Trial Information

Current as of December 27, 2024

Completed

Keywords

Placebos Anti Hiv Agents Adenine

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Laboratory diagnosis of HIV infection.
  • CD4 cell count \>= 200 cells/mm3 within 28 days prior to entry.
  • Plasma HIV RNA \>= 10,000 copies/ml within 28 days of entry.
  • Minimum life expectancy of 12 months.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with any of the following symptoms or conditions are excluded:
  • Active, serious infections (other than HIV) that require parental antibiotic therapy. Patients may be considered recovered if at least 2 weeks have elapsed following cessation of parental therapy before enrollment.
  • Active clinically significant medical problems that include cardiac disease (e.g., symptoms of ischemia, congestive heart failure, or arrhythmia).
  • Positive test for Hepatitis B surface antigen or Hepatitis C antibody in serum.
  • Patients with any of the following prior conditions are excluded:
  • History of malignancy other than basal cell carcinoma or cutaneous Kaposi's sarcoma.
  • Patients who are receiving:
  • Antiretroviral therapy, including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents.
  • Interferon or interleukin therapy, aminoglycoside antibiotics, amphotericin B, cidofovir, diuretics, foscarnet, ganciclovir, itraconazole, fluconazole, ketoconazole (topical allowed), isoniazid, rifampin, rifabutin, clarithromycin, azithromycin, systemic chemotherapeutic agents, systemic corticosteroids, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (probenecid) and other investigational agents.
  • Within 2 weeks prior to entry:
  • Antiretroviral therapy, including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents.
  • Interferon or interleukin therapy, aminoglycoside antibiotics, amphotericin B, cidofovir, diuretics, foscarnet, ganciclovir, itraconazole, fluconazole, ketoconazole (topical allowed), isoniazid, rifampin, rifabutin, clarithromycin, azithromycin, systemic chemotherapeutic agents, systemic corticosteroids, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (probenecid) and other investigational agents.
  • Active drug or alcohol abuse as demonstrated by a positive screening test for drugs of abuse (except marijuana or drugs used for medical indications), or substance abuse considered sufficient to hinder patient compliance.

About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to address unmet medical needs. With a strong emphasis on antiviral therapies, particularly for HIV, hepatitis B, hepatitis C, and influenza, Gilead leverages advanced research and development capabilities to drive breakthroughs in treatment and care. The company is committed to improving patient outcomes through rigorous clinical trials, fostering collaborations with healthcare professionals, and engaging in partnerships to enhance global health. Gilead's dedication to scientific excellence and patient-centric approaches positions it at the forefront of the biopharmaceutical industry.

Locations

Baltimore, Maryland, United States

San Francisco, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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